Label: PROPOLIMIX- sodium fluoride, allantoin liquid

  • NDC Code(s): 24765-002-01
  • Packager: Pharmacal-International. Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 23, 2024

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  • Active Ingredients                                                                 Purpose

    SODIUM FLUORIDE 0.02% ……..…………………………………………..…………Anticavity
    Allantoin 0.2% ……………………………………………………………………...…..……Antigingivitis

  • Purpose

    Anticavity, Antigingivitis, Clean mouth

  • Use

    • Aids in prevention of dental cavities.
    • Helps prevent and reduce plague (antiplague).
    • Helps to remove bad breath.
  • Warnings

    • Be careful not to swallow and rinse your mouth thoroughly after use.
    • Stop use and ask a dentist if oral irritation or tooth sensitivity occurs
    • Keep out of reach of children under the age of six, and if children under the age of six swallow large amounts, contact your doctor or dentist immediately.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Rinse mouth with this about 10~15ml for 30 seconds then expel

    Average daily dose
    Use twice a day after brushing, meals, and before social occasions.

  • Inactive Ingredients

    Glycerin, Xylitol, Sodium saccharin, Chitosan, Sodium benzoate, Citric acid, Sodium citrate, DL-malic acid, Acetic acid, Greentea extract, Turmeric extract, Ginger tincture, Propolis extract, Flavoring, Peppermint oil, L-menthol, Caramel coloring, Purified water

  • Storage method

    storage at room temperature (1~30℃)

  • Expiration date

    Separately marked

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    PROPOLIMIX 
    sodium fluoride, allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLIGLUSAM (UNII: 82LKS4QV2Y)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALIC ACID (UNII: 817L1N4CKP)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TURMERIC (UNII: 856YO1Z64F)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    2-(L-MENTHOXY)ETHANOL (UNII: 5ZWW23169H)  
    CARAMEL (UNII: T9D99G2B1R)  
    WATER (UNII: 059QF0KO0R)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-002-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2024
    Labeler - Pharmacal-International. Co., Ltd. (557805060)
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